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NCT06369467
Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy
Phase 1 trial testing linvoseltamab in Food Allergy in 6 participants. Currently enrolling.
28 March 2028
Quick facts
| Lead sponsor | Regeneron Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 17 May 2024 |
| Primary completion | 28 March 2028 |
| Estimated completion | 28 March 2028 |
| Sites | 7 locations across United States, Spain |
Drugs / interventions tested
- linvoseltamab (LINVOSELTAMAB) — full drug profile →
- dupilumab (DUPILUMAB) — full drug profile →
Conditions studied
- Food Allergy — all drugs for Food Allergy →
Sponsor
Regeneron Pharmaceuticals — full company profile →
Who can join
Adults 18 to 50, any sex, with Food Allergy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is researching an experimental drug called linvoseltamab combined with another drug called dupilumab. The study is looking at patients who have severe IgE-mediated food allergy. If the patient has an allergy, the body's defense system (immune system) overreacts to an allergen (eg, certain foods like peanuts, milk, shellfish) by making antibodies called IgE. An antibody is a protein that allows the immune system to find and fight off things the body does not recognize (allergens). IgE antibodies are sent out by cells like plasma cells. These antibodies and allergens bind to other cells that send out chemicals, causing an allergic reaction. The aim of the study is to see what side effects happen when linvoseltamab is combined with dupilumab. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * Does linvoseltamab combined with dupilumab affect other types of antibodies in the blood at different times * How much study drug(s) is in the blood at different times
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Advances in Shellfish Allergy Therapy: From Current Approaches to Future Strategies.
Heidari S, Ruethers T, Karnaneedi S, Yin LWS, et al · · 2025 · cited 4× · PMID 40668267 · DOI 10.1007/s12016-025-09077-8
Verify or expand the search:
- PubMed search for NCT06369467
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Food Allergy
Currently open trials in the same condition.
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- NCT06943534 — Omalizumab Weight-Based Dosing Efficacy Trial · Phase 2 · recruiting
- NCT06872996 — Trophallergen Prick Tests (PT) : Influence of Food Sample Shelf Life on the Reproducibility of PT Results · NA · recruiting
- NCT06529913 — Environmental Exposure to Heavy Metals, Nanoparticles, and Emergent Contaminants and Risk of Allergic Diseases · NA · recruiting
- NCT06558526 — Pectin Intervention Study and Long-term Follow-up in Lipid Transfer Proteins Allergic Patients · NA · recruiting
Other Regeneron Pharmaceuticals trials
Trials by the same sponsor.
- NCT07428369 — A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM) · Phase 2, PHASE3 · not yet recruiting
- NCT07526116 — A First in Human Study to Assess Safety, Tolerability and Pharmacokinetics of a Single Dose of REGN22044 in Healthy Adul · Phase 1 · not yet recruiting
- NCT07527923 — First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis · Phase 1 · not yet recruiting
- NCT07527910 — A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD · Phase 2 · not yet recruiting
- NCT07477704 — A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemi · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06369467 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Regeneron Pharmaceuticals
- Last refreshed: 13 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06369467.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing